1. Field of the Invention
The invention relates to assaying systems. More particularly, the invention relates to embodiments of machine readable assaying systems for analyzing a volume or specimen of physiological fluid to detect the presence, or absence, of particular substances therein.
2. Background and Objects of the Invention
The need to maintain confidentiality when performing an assay for substances that may be present in a volume of physiological fluid excreted or drawn from a donor is known in the art. If this confidentiality requirement extends to the assay administrator, the problem is exasperated, especially if the assay is to be performed `on-site`, say, at a place of employment. The confidentiality concerns remain valid whether attempting to detect the presence of a virus, the residue of a proscribed (e.g., illegal) drug, or other substances/items.
For example, the increase in the use of recreational drugs over the past several decades has created a sharp need for more effective, expeditious methods of analyzing whether a donor has used one or more proscribed substances. The need applies to a wide range of situations ranging from the testing of prospective employees for drug abuse, to the testing of race horses or athletes for the use of stimulants and enhancers. Consider the needs of private industry employers, as well as governmental agencies, to determine whether an individual has drug residue present in his or her (biological) system. Typically, the status of an individual as a substance abuser is determined by analysis of the individual's physiological fluids, namely urine. A volume of urine is collected, and a highly sensitive screening test performed, usually at a remote and centralized facility. If the volume tests positive at the central facility, then a second, possibly more sensitive, controlled confirmation analysis is generally performed.
The above procedure is plagued by several inherent and undesirable characteristics. In addition to potentially being a costly process, the above mentioned procedure also involves great time delays to employers desirous of obtaining new qualified employees. Upon collection of the urine sample, the employer must wait to receive test results from the central facility before hiring potential employees. Furthermore, the occurrence of errors due to the significant amount of handling, and the transfer of the volume from the initial collection site to the central facility, is problematic. Although, the confidentiality of donors is addressed through the use of the central (remote) facility, new and improved assaying systems and arrangements are needed.
To combat the above mentioned problems, which are faced by many private and corporate entities, various "on-site" or "hand-held" assaying devices have been developed. One major problem inherent in these "on-site" testing devices is that the privacy concerns of the potential employee being tested are not adequately addressed. Since generally all of the on-site testing devices available heretofore attempt merely to identify substances present (i.e. simply to indicate which specimens do indeed possess the substance being checked for), the anonymity of a presumptive positive donor is generally impossible to conceal. Due to such a lack of anonymity, many employers (governmental in particular) will not employ such assaying systems or devices as they do not comply with federally mandated regulations regarding the privacy and civil liberties of donor individuals.
Objects of the present invention are, therefore, to provide new and improved on-site assaying system having one or more of the following capabilities, features, advantages and/or characteristics:
an assaying system for analyzing a volume of physiological fluid to detect the absence or presence of at least one proscribed substance contained therein; PA1 a reliable and expeditious on-site assaying system wherein "results" are transmitted to and or stored at a remote location, such as a central facility for review (processing) and interpretation; PA1 maintains the privacy and anonymity of a donor (e.g., a prospective employee); PA1 provides test means wherein changes and results detected are not "human readable", and thus are not subject to interpretation and possibly unauthorized dissemination. PA1 a method of operation wherein test results can be obtained quickly without compromising the privacy concerns of the donor individuals being tested and or screened; PA1 an on-site, portable assaying system; PA1 an assaying system which allows the results of said assay to be encoded in a machine readable format (such as bar-coded indicia) such that the encoded results are visually undetectable and must be de-coded by appropriate apparatus; PA1 assaying means includes analysis strips that upon contacting, in a suitable manner, the physiological fluid to be tested, are capable of providing an optically detectable machine readable change indicating the presence or absence of one or more substances (within the fluid); PA1 inherently configurable to restrict an assay administrator's access to the assay results; PA1 a remote location may be efficiently employed to indicate the outcome of the assay activities, rapidly via "electronically" exchanged information and data, for example by way of a communication link established by a network or modem. PA1 may employ conventional bar-code reading apparatus, such as optical scanning units, to determine the (encoded) results of an assay; PA1 includes means capable of detecting adulteration of the volume of physiological fluid; PA1 includes means to determine if the assaying means is operating properly.
The above listed advantages, characteristics, objects, and or associated novel features of the present invention, as well as others, will become more clear from the description and figures provided herein. Attention is called to the fact, however, that the drawings are illustrative only. Variations are contemplated as being part of the invention, limited only by the scope of the appended claims.